BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1963423 · Received January 10, 2011

    Report

    Report Number
    9611594-2011-00006
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER DID NOT RETURN PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER WAS REMOVING A TAMPON AND THE TAMPON CAME APART INSIDE HER. CONSUMER INDICATED SOME OF THE PIECES REMAINED INSIDE AFTER REMOVAL OF THE TAMPON. THIS MALFUNCTION OCCURRED ON 7 SEPARATE OCCASIONS, EACH WITH A DIFFERENT TAMPON. THE CONSUMER EXPERIENCED SOME VAGINAL ITCHING, BURNING AND DISCHARGE AND HAS BEEN APPLYING MONISTAT TO THE IRRITATED VAGINAL AREA. CONSUMER INTENDS TO SEE HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT S. DE R.L. DE C.V. AA027301A1136

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR